FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K Number: K141785
·
Decision Mar 31, 2015
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
67
Applicant Total
3
Review Days
272
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Basic Information
- Device Name
- MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
- K Number
- K141785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bsd Medical Corp.
- Date Received
- July 2, 2014
- Decision Date
- March 31, 2015
- Product Code
- NEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
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